Establish a basic equipment management system to ensure that the equipment for the processed drugs in line with the process requirements, with the quality and content of uniformity, and minimize contamination and mixing accidents.
2. Scope
All equipment.
3, responsibility
Supervisory manager, equipment engineering department, workshop management personnel responsible for the management of this regulation, equipment engineering department is responsible for supervising the implementation of this regulation.
4, content
4.1 Equipment management organization and responsibilities
4.1.1 The company has a deputy general manager in charge of equipment work, under the equipment management department, workshop and production team, the formation of three-level management network.
4.1.2 Teams and workshops are responsible for the equipment management of their own departments, and the equipment management department is responsible for the comprehensive management of equipment in the whole plant.
4.1.3 The company is equipped with full-time and part-time equipment management personnel, and clear responsibilities.
4.2 Classification and numbering of equipment
4.2.1 The purpose of equipment classification is to clarify the scope of management, statistics and analysis of the composition of the equipment, capacity, etc., in order to carry out hierarchical management and the implementation of key maintenance in order to ensure that the equipment in good condition and utilization.
4.2.2 Equipment classification according to the object of management production equipment (I) auxiliary production equipment (II) non-production equipment (III).
4.2.3 Equipment numbering
4.2.3.1 Equipment numbering according to the following example:
Auxiliary serial number
Equipment serial number
Equipment management category number (I, II, III)
4.2.3.2 A number is used only once, no matter what happens to the numbered equipment, the number should be retained. retained and not used for other equipment.
4.2.3.3 Equipment attachments and ancillary equipment are not numbered separately, but may be numbered with an auxiliary number to distinguish them.
4.2.3.4 Production line equipment should be divided into a number of units according to the process attributes, one by one, the number of the connected part of the account can be attached to the nearest unit, the automatic line equipment should be a line for a device number.
4.2.3.5 Each set of equipment must be pinned in a conspicuous place on the fixed asset number plate.
4.3 The equipment register, the establishment of a ledger. Accounts include: serial number, fixed asset number, name and specifications, start time, original value, manufacturing unit, power, installation location, equipment category, the main body of material, weight, date of manufacture, attached to the motor model, location number, number, process media pressure, temperature, production capacity.
4.4 Establishment of equipment files
4.4.1 All equipment, pressure vessels, instruments, scales, etc. must be registered in a register.
4.4.2 Fixed assets equipment should be established accounts, cards, etc..
4.4.3 The content of the equipment card by: the main card, basic information, card schedules and change records.
(1) the main card: function, equipment number, asset number, equipment name, equipment properties, other items.
(2) Basic information of equipment: imported/domestic, original value, service life, net salvage ratio, annual depreciation rate, card delivery time, activation time, depreciation start time, activation department, evaluation, transfer, scrapping time, and remarks.
(3) Schedule of the card form: list of ancillary equipment, major accessories, consumable parts, random technical data and remarks.
(4) change records: record equipment removal, sealing, idle, credit, lease, transfer, scrapping, evaluation, transformation, overhaul and so on.
4.4.4 Equipment file content: see "equipment file management procedures".
4.5 Formulate the rules and regulations of the enterprise's equipment management, establish a set of scientific management methods, and implement them effectively.
4.6 Implement the national and higher authorities of the equipment management guidelines, policies, regulations, rules and methods.
4.7 Study, learn from foreign advanced management experience, the introduction of modern management techniques.
4.8 Regular organization of equipment management personnel, maintenance personnel, operators of business training, job training to improve the business level.
4.9 Regularly carry out the inspection, evaluation, exchange and assessment of equipment.
5, training and learning
Equipment Engineering Department and workshop supervisors or equipment personnel to seriously study the contents of this regulation.
4, content
4.1 Maintenance of the division of labor and responsibilities
4.1.1 The establishment of maintenance management organization, with the corresponding management system, to avoid the emergence of responsibility gaps and overlapping phenomenon, the formation of a complete and effective maintenance management system.
4.1.2 Define departmental responsibilities
(1) equipment management personnel: the development of equipment maintenance, repair plans; the preparation of technical documents for maintenance (including: spare parts list, materials list, tools list, fixed maintenance process, fixed maintenance standards, fixed test procedures, fixed time quota, fixed duration); outsourcing construction budgets and contracts.
(2) Specialized technical personnel: equipment integrity inspection, technical condition testing, technical quality assessment.
(3) Spare parts management personnel: preparation of maintenance supplies, spare parts and materials.
(4) Maintenance personnel: preparation of tools, preparation of work plans, repair construction work.
(5) Users: maintenance implementation, operation status monitoring.
(6) maintenance personnel and the use of personnel **** with filling out equipment repair and maintenance records.
4.2 Equipment Maintenance
4.2.1 Daily Maintenance: Every day after work, 15 minutes before work ~ 30 minutes by the operator to carry out the equipment for inspection or cleaning and wiping test, so that the equipment is in a neat, clean, safe, well-lubricated state.
4.2.1.1 The integrity of the equipment, parts, accessories are missing.
4.2.1.2 Run the equipment first idle, confirm the sound is correct, lubrication is complete, before regular operation.
4.2.1.3 Check the screws, tighten the screws to prevent the use of shedding.
4.2.1.4 Check whether the complete protection device is intact, safe, flexible, accurate and reliable.
4.2.1.5 Check whether the lubrication device is complete, intact, reliable, the oil circuit is smooth, and the oil label is visible.
4.2.1.6 Lubrication and refueling of the rotating parts, check the transmission system of the operating vehicle, electrical open point position correctly without loosening, flexible and reliable operation.
4.2.1.7 Check all kinds of pipelines, fittings intact, no dripping phenomenon.
4.2.1.8 Clean the equipment parts, so that the equipment inside and outside clean, sliding rails and joints without oil rust, dust and debris, so that the paint to see the color of the iron to see the light.
4.2.1.9 All kinds of tools, accessories should be arranged in an orderly manner, stored neatly.
4.2.10 Strictly according to the operating procedures for the use of equipment. Frequent inspection tours, through listening, watching, asking and other methods to observe the operation of the equipment up to, found that the problem is dealt with in a timely manner.
4.2.2 The first level of maintenance, set at about three months once, in addition to the electrical part of the electrician is responsible for the rest of the operator, workshop equipment management personnel to assist and guide the maintenance content.
4.2.2.1 Cleaning, inspection, adjustment of electrical parts, check whether the electrical contact is good. Wiring is solid.
4.2.2.2 Thoroughly clean and scrub the internal and external surfaces of the equipment and dead ends. Remove surface burrs, so that the paint to see the original color, iron to see the light, remove the scale, no pollution.
4.2.2.3 Check and adjust the necessary parts, adjust the clearance of each moving part, replace the wearing parts.
4.2.2.4 Check the fasteners and operating devices to be safe and reliable.
4.2.2.5 Check and replace various measuring instruments and safety accessories.
4.2.2.6 Clean the oil cup, oil pipe, oil label, check the oil quality, refueling in accordance with the provisions of the oil, so that the oil circuit is smooth and the oil label is conspicuous.
4.2.2.7 Troubleshooting and eliminating hidden dangers.
4.2.2.8 If necessary, disassemble and inspect the equipment avoidance part, adjust and repair.
4.2.2.9 The first level of maintenance should meet the standards.
4.2.2.9.1 Appearance is clean, showing the original color.
4.2.2.9.2 The oil circuit is smooth and the oil chamber is bright.
4.2.2..9.3 Good lubrication and low wear of the equipment.
4.2.2.9.4 Equipment defects are eliminated, and potential accident hazards disappear.
4.2.2.9.5 The equipment runs normally, operates flexibly and remains in perfect condition.
4.2.3 secondary maintenance depending on the different equipment is generally carried out once a year, the main maintenance personnel, the operator to participate.
4.2.3.1 Completion of the first level of maintenance of all checks.
4.2.3.2 Check the transmission system repair, replacement of wear parts.
4.2.3.3 Clean the change box or transmission.
4.2.3.4 Adjust and check each operating vehicle to make it flexible and reliable.
4.2.3.5 Clean the motor, replace the lubricant, and check the motor insulation.
4.2.3.6 Organize the electrical wiring, make the wiring neat and safe, and the grounding wire conforms to the regulations.
4.2.3.7 Replace the oil with new one and eliminate the oil leakage.
4.2.3.8 Partial disassembly of the equipment for inspection, adjustment, repair and replacement of parts when necessary.
4.2.3.9 The equipment reaches the standard of fixed goodness after the second level of maintenance, and improves the rate of equipment completion during the interval of overhaul.
4.3 Overhaul of equipment
4.3.1 Guidelines and principles of overhaul
4.3.1.1 Overhaul of equipment refers to the "recovery" of the technical state of the various parts of the equipment and the ability to work on the work.
4.3.1.2 Equipment overhaul should adhere to the policy of prevention first, the implementation of planned maintenance.
4.1.1.3 The main equipment for an annual condition census, according to the actual state of equipment operation and census. By the equipment management department to prepare equipment for major and medium-sized repair program. Reviewed and approved by the competent leader.
4.3.2 Overhaul of equipment, first of all, to develop "equipment maintenance and overhaul procedures" its content:
a, overhaul intervals; b, overhaul content; c, overhaul of the preparations (technical preparation, material preparation, safety and technical preparations, the development of overhaul programs, the preparation of overhaul programs, cost plans, clear responsibility for the staff); d, overhaul program (equipment disassembly procedures and methods, the main components overhaul process); e, overhaul program (equipment disassembly procedures and methods, the main components overhaul process); f, overhaul program (equipment disassembly procedures and methods, the main components overhaul process). Main parts overhaul process); e, overhaul quality standards; f, commissioning and acceptance; g, maintenance and common faults.
4.3.3 Preparation of maintenance plan
4.3.3.1 Equipment maintenance plan is divided into annual and monthly plans.
Annual plan provides for equipment overhaul, item repair, precision adjustment of the time period, the contents of which include the annual maintenance schedule, overhaul plan task book.
Monthly plan should specify the implementation date of the above maintenance and minor repairs, part of the aftermath of the maintenance content.
4.3.3.2 The basis for the preparation of the plan:
a, equipment testing and maintenance, operation records; b, equipment failure records and analysis of information; c, equipment technical condition census information; d, product quality requirements for equipment accuracy, performance, equipment capacity index, etc.; e, pressure vessels, lifting equipment, kinetic equipment, condition monitoring or test results and other analytical information; f, reference equipment repair cycle and repair. , reference equipment repair cycle and repair complexity coefficients and various quota information; g, the enterprise's annual production and operation program; h, the enterprise's annual maintenance force, people, money and material use; i, the limit of the period of time for the repair of the preparatory work before the limit.
4.3.3.3 Indicators of the plan assessment:
Repair cost = material cost + spare parts cost + consumed repair equipment shift cost + labor cost (yuan)
Consumed man hours = work × day (man days)
Stop time (days)
Equipment repair rate = the actual number of units returned to repair / planned repair unit x 100%
4.3.4 The scope of equipment overhaul, overhaul, medium repair and minor repair should be strictly divided into areas.
4.3.4.1 Overhaul: decomposition of the entire equipment, repair of benchmarks, replacement or repair of all wear parts, adjust the electrical parts, remove defects, restore the original performance of the equipment, accuracy and efficiency, renovation of the appearance.
4.3.4.2 Medium Repair: part of the equipment decomposition, repair and replacement of some of the wear parts, precision, performance does not meet the process requirements of the targeted repair parts, to restore its precision, performance.
4.3.4.3 small repair: for the daily inspection of the problems found, dismantle some parts for inspection, repair, replacement or repair quality of a small number of wear parts. At the same time check, adjust, fasten the machine to restore the use of equipment performance.
4.4 Specific procedures for equipment overhaul
4.4.1 with the overhaul plan to be carried out in accordance with the annual overhaul plan, and the development of overhaul programs.
4.4.2 According to the main equipment overhaul program, the strict implementation of overhaul technical standards.
4.4.3 Key equipment overhaul or overhaul to achieve technological innovation, reported to the equipment management department, with drawings to illustrate, approved for implementation.
4.4.4 Overhaul to gradually adopt condition monitoring and modern fault diagnosis and other technologies, and strive to use new technologies, new techniques, new materials, new equipment.
4.4.5 Inspection should be carried out outside the production area. Technical preparation and preparation of materials and spare parts should be done before overhauling, and after overhauling, the work should be done, the material is clean, and the site is clear.
4.4.6 Equipment major and medium repair plan should be issued at the same time as the production plan, in the inspection of production completion, while checking the completion of equipment maintenance assessment.
4.4.7 After the inspection and repair of the equipment should be organized by the equipment management department qualified personnel inspection before being put into normal production and use, all records should be carefully filled out and filed.
5, training and learning
Equipment operators, maintenance personnel, workshop equipment management personnel to seriously study the regulations and participate in training.
4.1 All equipment should be classified and registered, unified number, the establishment of accounts and cards, the establishment of technical files, to achieve a machine a file.
4.2 The establishment of the equipment file, can specifically reflect the movement of the equipment throughout its life.
4.3 Equipment technical file work by the equipment engineering department to designate a person responsible for, and the establishment of equipment file cabinet.
4.4 Equipment engineering department is responsible for the management of the work of the documents, the form of materials, collection, collation, identification, archiving.
4.5 Procurement, custody, maintenance and management at all levels should assist in making the perfect technical file and collection and conscientiously do a good job of all kinds of original information custody, fill out all kinds of original forms, to ensure that the information is complete and neat, identification and acceptance of the production, to the archives cabinet unified organization and filing.
4.6 Infrastructure, technical reform projects to hand over all production data must be transferred to the equipment management department in a timely manner to organize and archive.
4.7 The late management of the equipment occurred during the operation of information such as various types of records, etc., are organized and filed by the equipment management department.
4.8 file content should include:
4.8.1 original technical data: packing list, certificate of conformity, purchase application form, instruction manuals, equipment assembly and installation, lifting diagram, construction drawings, equipment lubrication diagrams and unpacking acceptance form.
4.8.2 Equipment history: equipment name, number, production plant name, factory date, the main technical parameters of the workshop, the installation site, the name of ancillary equipment, specifications, models, pieces (units) and change records.
4.8.3 List of wearing parts.
4.8.4 Various records: installation and commissioning records, daily operation and use records, maintenance records, accident records, verification records, lubrication records.
4.8.5 Equipment transformation of the demonstration, technical appraisal and technical accounts of its content:
4.8.5.1 The verification of the main equipment information.
4.8.5.2 The main equipment technical summary table (equipment integrity rate, leakage rate and the main defects of equipment).
4.8.5.3 Summary table of equipment maintenance status (overhaul projects, actual completion of projects, unplanned projects, planned maintenance hours, actual completion of maintenance hours, maintenance costs, etc.).
4.8.5.4 Equipment accident summary table (number of accidents, downtime, downtime loss).
4.8.5.5 The main equipment technology innovation results summary table.
4.8.5.6 Summary table of equipment spare parts, material consumption.
4.9 Commonly used information to establish a backup and should be regularly counted, check, and timely replenishment and repair of damaged or deteriorated information. File transfer or transfer of management personnel must go through the transfer procedures.
4.10 Requests for information, access to information should be approved by the registration can not be privately copy the material. Need to copy the material should be implemented by the equipment management personnel.
4.11 The content of the equipment file to fill in the handwriting should be standardized, neat and clear.
4.12 files are generally not allowed to borrow, special circumstances need to be approved and carefully registered before lending.
4.13 Annual technical files should be organized.
5, training and learning
Archive management personnel need to participate in the training and learning of this regulation.
4.1 equipment lubrication management to implement the "five", "three filtering", strict implementation of "equipment lubrication management regulations", and in line with the "pharmaceutical industry equipment integrity Standard" in Appendix F "equipment lubrication requirements".
4.1.1 "five fixed"
4.1.1.1 fixed people: each piece of equipment should be clearly specified by the operator, maintenance personnel and equipment managers are responsible for refueling parts.
4.1.1.2 fixed point: each piece of equipment has a defined lubrication parts and lubrication points.
4.1.1.3 fixed quality: in accordance with the equipment instruction manual or lubrication with the table specified grease grade oil.
Lubrication devices, oil lines and oiler must be kept clean, oil should be inspection certificate.
4.1.1.4 quantitative: to ensure good lubrication on the basis of quantitative consumption.
4.1.1.5 Timing: clearly specify the equipment lubrication parts, lubrication point refueling intervals, according to the time required to refuel oil and cleaning oil, to ensure normal lubrication.
4.1.2 "three filters": that is, the oil drum, oil pot, refueling point (hole) of the three filters.
4.1.2.1 The lubricant is filtered from the oil drum to the oil tank by one level.
4.1.2.2 The lubricant is filtered from the oil tank to the oil pot through the second level.
4.1.2.3 The lubricating oil is filtered from the oil pot to the refueling point of the equipment through the tertiary filtration.
4.2 The main equipment to establish a lubrication card, including: lubrication points, oil quality, "five" and other items.
4.3 Equipment engineering department should prepare various types of equipment oil consumption quota, the preparation of the year, quarter, month of lubricating oil and grease use plan, implemented to the workshop, team, machine, and the actual consumption of statistics on a regular basis, to achieve the plan to use the oil, reasonable use of oil, oil saving.
4.4 The workshop equipment manager should supervise and check the cleaning and oil change work according to the oil change cycle of the equipment, and prepare the annual, quarterly and monthly lubricant use plan of the workshop. Fill in the workshop lubrication records of major equipment, reported to the equipment management department.
4.5 Equipment operators should be in accordance with the "five" specification to understand the lubrication requirements of the equipment and seriously implement. The automatic oil lubrication point should always check the screen, oil level, oil pressure, oil temperature, oil quality, oil injection volume, shift handover will be the above situation and the "five" "three filters" fill in the lubrication card.
4.6 The storage and management of oil, according to the different types of labeling, separate storage, to prevent misdirection and fire.
4.7 The distribution of lubricants, according to the equipment lubrication card filled in the oil quality, oil quantity and other standards issued, is strictly prohibited abuse or substitution.
4.8 Pay attention to the recovery of lubricating oil after use, and the recovered oil should be kept separately according to the brand number.
4.9 All the lubricants and coolants used in the equipment can not react with the drugs, so as not to cause pollution.
4.10 For lubricants used in parts that have potential contact with drugs, the variety should be fixed, and if the variety is changed, it should be evaluated.
4.11 The storage of lubricants should be well ventilated, less dusty and with necessary fire fighting facilities.
4.12 Different types of lubricants should be clearly marked so as not to get the wrong number, and the storage of oil in drums should be cited in special drums.
4.13 Strictly according to the quota of oil supply, such as more than the quota of oil, need to be studied and approved by the equipment maintenance class.
4.14 The apparatus used to issue oil should be specialized, so as not to issue the wrong oil.
5, training and learning
Operators, maintenance personnel, equipment managers, equipment management is responsible for the training and learning of this regulation.
.1 equipment and instrumentation due to abnormal damage, resulting in production stoppages, production reduction, power supply interruption, reduced efficiency, personal injury or death are equipment accidents.
4.2 Equipment accidents are divided into general accidents, major accidents, major accidents.
4.2.1 General accidents, equipment parts damage, repair costs of more than 500 yuan or affect the day's production of more than 5%.
4.2.2 Major accidents
4.2.2.1 Serious damage to equipment, the repair cost of 6000 yuan to 10,000 yuan or affect the day's production of more than 25%.
4.2.2.2 Although the above damage is not reached, but the nature of the seriousness of the situation is also classified as a major accident.
4.2.3 Major accidents are classified as major accidents if one of them is met.
4.2.3.1 Serious equipment damage, repair costs in more than 10,000 yuan.
4.2.3.2 The accident caused three or more serious injuries.
4.2.3.3 The accident caused death.
4.2.3.4 Other accidents of a serious nature.
4.3 Characterization of equipment accidents
4.3.1 Responsible accidents: non-compliance with standard operating procedures, unauthorized absence from duty, improper maintenance, equipment overloaded support rotary equipment damage. Shutdown or reduce the effectiveness of the responsible accident.
4.3.2 Quality accidents: equipment due to design, manufacturing, poor quality, improper installation or maintenance caused by improper damage, shutdown or reduced efficiency for quality accidents.
4.3.3 Natural accidents: equipment damage caused by natural disasters for natural accidents.
4.4 Causes of accidents
4.4.1 After the occurrence of equipment accidents, the operation should be stopped immediately, protect the scene, do not touch and move the scene of the goods, and at the same time reported to the competent authorities. Major and major accidents should be promptly reported to the higher authorities and take urgent measures to prevent further expansion of the accident.
4.4.2 equipment accidents occur, in line with the "three don't let go" (the cause of the analysis is not clear don't let go, the responsible person and the masses have no education don't let go, no precautionary measures don't let go) principle, by the equipment management department to organize the relevant personnel to watch the scene, on-site analysis of attention to the collection of raw data and vouchers or video retain the original condition data for detailed records. Video to retain the original condition information for detailed records.
4.4.3 After the accident, the workshop equipment manager fill in the accident report in time, reported to the equipment engineering department. Major and major accidents should be reported to higher authorities within 24 hours.
4.5 Handling of accidents
4.5.1 Production stoppage caused by equipment accidents should be actively organized to repair the equipment, and effective remedial measures should be taken to resume production as soon as possible before repair. Major and major accidents should be proposed to repair the program and improve the measures.
4.5.2 General equipment accidents signed by the Equipment Engineering Department to deal with the views of the major, major accidents by the manager in charge of the approval, and wait for the higher authorities to deal with.
4.5.3 The person responsible for the accident according to the severity of the circumstances, the size of the responsibility, attitude and good or bad to criticize and educate or administrative and economic
punishment, violation of the law to be held criminally responsible.
4.5.4 For concealing and not reporting, intentionally minimizing the accident, falsification, to increase the penalties and hold the leadership responsible.
4.5.5 All records of equipment accidents, original information or vouchers, technical appraisal, investigation and analysis reports, repair programs should be filed.
5, training and learning
Operators, equipment managers, workshop managers, equipment management should seriously participate in the training and learning of this regulation.
4.1 All use of equipment should have a uniform number, the number should be marked on the main body of the equipment, each piece of equipment should be set up to manage.
4.2 Each piece of equipment should be hung on the status of the signage, hung in a location that is not easy to fall off, the specifics are as follows:
4.2.1 Running: the production of the operation of the equipment, should be correctly indicating the name of the material, batch number, number, date of production, the operator and so on.
4.2.2 Under repair: equipment under repair, should be marked with the starting time of repair, the person in charge of maintenance.
4.2.3 has been cleaned: has been cleaned clean equipment, readily available to mark the date of cleaning.
4.2.4 to be cleaned: not yet cleaned equipment, with obvious symbols to avoid misuse.
4.2.5 deactivation: due to changes in production structure or other reasons for temporary use of equipment such as long-term use should be removed from the production area.
4.2.6 pending maintenance: equipment failure has not been scheduled for maintenance program.
4.3 A variety of pipelines and pipelines in addition to the required color, there should be marked medium flow direction of the arrow and flow location.
4.4 Aseptic equipment should be marked sterilization time and use of the period, more than the sterilization period, should be re-sterilized after use.
4.5 When the state of the equipment changes, the license plate should be changed in time to avoid errors.
4.6 All signs should be hung in obvious parts for observation.
5, training and learning
Equipment operators should receive training and learning of this regulation.